[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517478":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":34,"responsibleParty":53,"collaborators":20,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":20,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":20,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Children's Mercy Hospital Kansas City","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Interventional Arm","EXPERIMENTAL","Subjects who are placed in the Prone Positioner for evaluation",[13],"Device: Prone Positioner",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Prone Positioner","An innovative device to allow for infants to be supported while in the prone position",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Brandi Dorton, DPT, NTMTC","Children's Mercy Kansas City","PRINCIPAL_INVESTIGATOR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","8162343380","bbdorton@cmh.edu",{"name":32,"role":28,"phone":20,"phoneExt":20,"email":33},"Jennifer A Marshall, MPH, RN","jamarshall@cmh.edu",[35],{"facility":24,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"RECRUITING","Kansas City","Missouri","64108","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-94.57857,39.09973,{"lat":46,"lon":45},[49,50],{"name":23,"role":28,"phone":20,"phoneExt":20,"email":30},{"name":51,"role":28,"phone":52,"phoneExt":20,"email":33},"Jennifer Marshall, MPH, RN","9132449566",{"type":25,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Brandi Dorton","Principal Investigator","100517478","investigating-fit-and-satisfaction-of-the-prone-positioner-100517478",false,"NCT06018064","Investigating Fit and Satisfaction of the Prone Positioner","Investigating the Fit and Satisfaction of an Innovative Device - Prone to Excellence: A Tummy Time Device Prone Positioner for Infants With Medical Complexities Including Artificial Airways: A Design Pilot Study","Inclusion Criteria:\n\n* Inpatient infants located on the Pediatric Intensive Care Unit (PICU) or (Neonatal Intensive Care Unit (NICU) or being seen in the Vent clinic at Children's Mercy with tracheostomies between the ages of \\>44 weeks gestational age to 24 months of age with various size\u002Fweights of infants.\n* Any race\u002Fethnicity\n* English speaker\n* Males and females\n* Caregivers\n* Children's Mercy (CM) Occupational Therapists (OTs), Physical Therapists (PTs), Speech Therapists (STs) who have not seen the new prone positioner device.\n\nExclusion Criteria:\n\n* Infants \\> 24 months of age\n* Infants medically unstable as determined by attending physician in the PICU\u002FNICU or Vent Clinic\n* Infants with recent cardiac or abdominal surgery who have precautions or complications related to their surgery.\n* Infants with weightbearing restrictions\u002Ffractures in their upper extremities.\n* Non-English speakers \\* Wards of the state","ALL","44 Weeks","24 Months",{"count":67,"type":68},30,"ESTIMATED","INTERVENTIONAL",[71],"NA","The goal of this clinical trial is to learn about the use of the Prone Positioner in pediatric patients with tracheostomies (trachs). The main question\\[s\\] it aims to answer are:\n\n* What is the fit and satisfaction of the device?\n* Does the device fulfill the goal of allowing infants with trachs participate in tummy time\n* What aesthetic feedback will the study team receive on the prone positioner from families, therapists, and nursing staff.\n\nParticipants will be placed in the Prone Positioner, they will be monitored for their comfort\u002Fsatisfaction with use, and how well they are able to be receive ventilation while in the device. Parents of these infants, as well as healthcare providers, will be surveyed on thoughts\u002Fsuggestions for the Prone Positioner.",[74],"Infant Development","2025-12-01",{"date":77,"type":78},"2025-12-05","ACTUAL",{"date":80,"type":78},"2023-09-21",{"date":82,"type":68},"2028-09",{"name":5,"class":6},1]